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FDA Expands Nivolumab Lung Cancer Approval

Dr. Richard Pazdur

Richard Pazdur, MD

Acting 3 months ahead of schedule, the FDA approved nivolumab (Opdivo) for patients with nonsquamous non–small cell lung cancer (NSCLC) who progressed on or following platinum-based chemotherapy.

The approval is based on data from the phase III CheckMate-057 trial, in which second-line nivolumab reduced the risk of death by 27% versus docetaxel in patients with nonsquamous NSCLC, including a 60% risk reduction among patients with the highest levels of PD-L1 expression.

"There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit." Click here to read the full article at

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